SDS: Methylene Blue Injection, USP 1%
SAFETY DATA SHEET
1.
2.
3.
Identification
Product Identifier:
Methylene Blue Injection, USP 1%
Synonyms:
Methylthioninium chloride * C.I. Basic Blue 9 trihydrate
National Drug Code (NDC):
17478-504-01
17478-504-10
Recommended Use:
Pharmaceutical.
Company:
Akorn, Inc.
1925 West Field Court, Suite 300
Lake Forest, Illinois 60045
Contact Telephone:
1-800-932-5676
E mail:
[email protected]
Emergency Phone Number:
CHEMTREC 1-800-424-9300 (U.S. and Canada)
Hazard(s) Identification
Physical Hazards:
Health Hazards:
Symbol(s):
Signal Word:
Hazard Statement(s):
Precautionary Statement(s):
Hazards Not Otherwise Classified:
Not classifiable.
Not classifiable.
None.
None.
None.
None.
Not classifiable.
Supplementary Information:
This material is considered hazardous by OSHA Hazard
Communication Standard (29 CFR 1910.1200).
Composition/Information on Ingredients
Chemical Name
Methylene Blue
CAS
Number
7220-79-3
Synonyms
Methylthioninium
chloride * C.I. Basic
Blue 9 trihydrate
Chemical
Formula
C16H18ClN3S
Molecular
Weight
319.86
Percentage
1%
*The formula also contains Water for Injection, Sodium Hydroxide and/or Hydrochloric Acid to adjust pH.
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SDS: Methylene Blue Injection, USP 1%
4.
First Aid Measures
Ingestion:
If a person vomits place them in the recovery position so
that vomit will not reenter the mouth and throat. Rinse
mouth with water. If swallowed, seek medical advice
immediately and show the container or label. Treat
symptomatically and supportively. Ensure that medical
personnel are aware of the material(s) involved and take
precautions to protect themselves.
Eye Contact:
Remove from source of exposure. Flush with copious
amounts of water for at least 15 minutes. If irritation
persists or signs of toxicity occur, seek medical attention.
Provide symptomatic/supportive care as necessary.
Ensure that medical personnel are aware of the
material(s) involved and are aware of precautions to
protect themselves.
Skin Contact:
Remove from source of exposure. Remove and isolate
contaminated clothing and shoes. Flush with copious
amounts of water for at least 20 minutes. Use soap. If
irritation persists or signs of toxicity occur, seek medical
attention. Provide symptomatic/supportive care as
necessary. Ensure that medical personnel are aware of
the material(s) involved and are aware of precautions to
protect themselves.
Inhalation:
Remove from source of exposure. Move individual(s) to
fresh air. Give artificial respiration if individual(s) are not
breathing and call emergency medical service. If signs of
toxicity occur, seek medical attention. Provide
symptomatic/supportive care as necessary. Ensure that
medical personnel are aware of the material(s) involved
and are aware of precautions to protect themselves.
Protection of First-Aiders:
Use personal protective equipment (see section 8).
Signs and Symptoms:
See package insert for more information.
Medical Conditions Aggravated
by Exposure:
Notes to Physician:
5.
Personnel with central nervous system and hemopoietic
disorders.
Exposure to product may result in headache, confusion,
dizziness and nausea. May cause precordial and
abdominal pain and the formation of methemoglobin.
See prescribing information.
Firefighting Measures
Suitable Extinguishing Media:
Water spray, foam, dry chemical of carbon dioxide.
CAUTION: Carbon dioxide will displace air in confined
spaces and may cause oxygen deficient atmosphere.
Unsuitable Extinguishing Media:
None.
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SDS: Methylene Blue Injection, USP 1%
Specific Hazards Arising from the Chemical:
Hazardous Combustion Products:
When heated methylene blue solution thermally
decomposes to form toxic vapors. (i.e. Carbon
Monoxide, Carbon Dioxide, Halogenated Compounds
and Oxides of Sulfur and Nitrogen.)
Other Specific Hazards:
Not determined.
Special Protective Equipment/
Precautions for Firefighters:
6.
7.
Methylene blue solution thermally decomposes to form
toxic vapors. Vapors may be irritating to eyes and skin,
and may be toxic to respiratory tract. Firefighters are to
wear self-contained breathing apparatus (SCBA) and full
turn out gear (Bunker gear). Cool containers with water
spray and use caution when approaching.
Accidental Release Measures
Personal Precautions:
Use personal protective equipment recommended in
Section 8 of this document and isolate the hazard area.
Personal Protective Equipment:
For personal protection see section 8.
Methods for Cleaning Up:
Vacuum spillage with a vacuum cleaner having a high
efficiency particulate (HEPA) filter, or absorb liquid with
clay absorbent, absorbent pads or paper towels. Use
plastic tools to scoop up, sweep or containerize spilled
material. Use plastic drums to contain spilled materials.
Wipe working surfaces to dryness, and then wash with
soap and water. Dispose of material according to
Federal, State and Local regulations.
Environmental Precautions:
This material is not considered a water pollutant.
However, it is recommended to prevent spilled or leaking
material from entering waterways. Minimize the use of
water to prevent environmental contamination.
Reference to Other Sections:
Refer to Sections 8, 12 and 13 for further information.
Handling and Storage
Precautions for Safe Handling:
Conditions for Safe Storage,
Including Any Incompatibilities:
Specific End Use:
Avoid all contact and inhalation of mists or vapors
associates with the product. Avoid contact with skin,
eyes, and clothing. Do not mix with other drugs.
Handle in accordance with product label and/or product
insert information. Handle in accordance with good
industrial hygiene and safety practices.
Store between 20°C – 25°C (68°F – 77°F). Store
according to label and/or product insert information.
Pharmaceuticals.
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SDS: Methylene Blue Injection, USP 1%
8.
Exposure Controls/Personal Protection
Occupational Exposure Guidelines:
Common or Chemical Name
Methylene Blue
Sodium Hydroxide
Hydrochloric Acid
9.
Employee Exposure Limits
Not established.
OSHA PEL 2 milligrams/cubic Meter – 8 hour TWA
ACGIH TLV 2 milligrams/cubic meter – Ceiling
OSHA PEL 5 parts per million – Ceiling
ACGIH TLV 2 parts per million – Ceiling
Engineering Controls:
Engineering controls should be used as the primary
means to control exposures.
Respiratory Protection:
Where respirators are deemed necessary to reduce or
control occupational exposures, use NIOSH-approved
respiratory protection and have an effective respirator
program in place (applicable U.S. regulation OSHA 29
CFR 1910.134).
Eyes Protection:
Not required for the normal use of this product. Safety
glasses with side shields are recommended. Face
shields or goggles may be required if splash potential
exists or if corrosive materials are present. Approved
eye protection (e.g., bearing the ANSI Z87 or CSA
stamp) is preferred. Maintain eyewash facilities in the
work area.
Hand Protection:
Not required for the normal use of this product.
Chemically compatible gloves. For handling solutions,
ensure that the glove material is protective against the
solvent being used. Use handling practices that minimize
direct hand contact. Employees who are sensitive to
natural rubber (latex) should use nitrile or other synthetic
non-latex gloves. Use of powdered latex gloves should
be avoided due to the risk of latex allergy.
Skin Protection:
Not required for the normal use of this product. Wear
protective laboratory coat, apron, or disposable garment
when working with large quantities.
Physical and Chemical Properties
Physical State/Color:
Odor:
Odor Threshold:
pH:
Melting Point:
Freezing Point:
Boiling Point:
Flash Point:
Evaporation Rate:
Flammability (solid, gas):
Flammability Limit - Lower:
Dark blue solution.
Odorless.
No data available.
3.0 - 4.5.
No data available.
Approximately 32°F.
Approximately 212°F.
No data available.
No data available.
Nonflammable, noncombustible.
No data available.
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SDS: Methylene Blue Injection, USP 1%
Flammability Limit - Upper:
Vapor Pressure:
Vapor Density:
Relative Density:
Solubility(ies):
Partition Coefficient
(n-octanol/water):
Auto-Ignition Temperature:
Decomposition Temperature:
Viscosity:
10.
No data available.
No data available.
No data available.
No data available.
Stability and Reactivity
Reactivity:
No data available.
Chemical Stability:
Stable under recommended storage conditions.
Possibility of Hazardous Reactions:
No data available.
Conditions to Avoid (e.g., static
discharge, shock, or vibration):
Incompatible Materials:
Hazardous Decomposition
Products:
Hazardous Polymerization:
11.
No data available.
No data available.
No data available.
No data available.
Freely soluble in water and alcohol.
Do not mix with other drugs. Avoid heat, light and
humidity. Keep away from flames, thermally
decomposes to form toxic vapors.
Reactive with strong Oxidizers and Alkalis.
Carbon monoxide, carbon dioxide, halogenated
compounds, oxides of sulfur and nitrogen may be
released by thermal decomposition.
Does not occur.
Toxicological Information
Information on the Likely Routes of Exposure:
Inhalation:
Cause irritation to the respiratory system.
Ingestion:
Causes irritation of the gastrointestinal tract.
Skin Contact:
May cause skin irritation.
Eye Contact:
Causes eye irritation.
Symptoms Related to the Physical,
Chemical and Toxicological
Characteristics:
See Section 4. To the best of our knowledge, the
chemical, physical and toxicological properties have not
been thoroughly investigated.
Delayed and Immediate Effects of
Exposure:
No data available.
Acute Toxicity – Oral:
Acute Toxicity – Dermal:
Acute Toxicity – Inhalation:
No data available.
No data available.
No data available.
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SDS: Methylene Blue Injection, USP 1%
12.
Corrosivity:
No data available.
Dermal Irritation:
May cause skin irritation.
Eye Irritation:
Causes eye irritation.
Sensitization:
Toxicokinetics/Metabolism:
No data available.
No data available.
Target Organ Effects:
May be toxic to lungs, eyes, hemopoietic and central
nervous system.
Reproductive Effects:
Animal studies concerning Methylene Blue illustrated
adverse effects, decreased sperm motility. No adequate
and well controlled studies in humans concerning the
reproductive effects of Methylene Blue.
Carcinogenicity:
Methylene Blue is not considered carcinogenic. No
adequate and well controlled studies in humans
concerning the carcinogenic effects of Methylene Blue.
National Toxicology Program (NTP):
Not considered to be a carcinogen.
International Agency for Research on
Cancer (IARC):
Not considered to be a carcinogen.
Occupational Safety and Health
Administration (OSHA):
Not considered to be a carcinogen.
Mutagenicity:
Methylene blue is mutagenic in bacteria, yeast and
somatic mammalian cells. No adequate and well
controlled studies in humans concerning the mutagenic
effects of Methylene Blue.
Aspiration Hazard:
No data available.
Ecological Information
Ecotoxicity
Aquatic:
Terrestrial:
No data available.
No data available.
Persistence and Degradability:
Short term products of biodegradation are not likely. No
data available on the long term degradation of the
product.
Bioaccumulative Potential:
No applicable bioaccumulation is expected in the
environment.
Mobility in Soil:
No data available.
Mobility in Environment:
With respect to mobility in the environment, appreciable
volatilization is not expected into the air or aquatic
environment.
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SDS: Methylene Blue Injection, USP 1%
Other Adverse Effects:
13.
No data available.
Disposal Considerations
Dispose of all waste in accordance with Federal, State and Local regulations.
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15.
Transport Information
UN Number:
UN Proper Shipping Name:
Transport Hazard Class(es):
Packing Group:
Not applicable.
Not applicable.
Not applicable.
Not applicable.
Department of Transportation:
Not regulated as a hazardous material.
International Air Transport
Association (IATA):
Not regulated as a dangerous good.
International Maritime Dangerous
Good (IMDG):
Not regulated as a dangerous good.
Regulatory Information
US Federal Regulations:
Toxic Substance Control Act
(TSCA):
Not listed.
CERCLA Hazardous Substance
and Reportable Quantity:
Not listed.
SARA 313:
SARA 302:
Not listed.
Not listed.
State Regulations
California Proposition 65:
16.
Not listed.
Other Information
NFPA Rating:
Health:
Fire:
Reactivity:
1
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0
Revision Date: 05/04/2015
Revision Number: 1
Disclaimer: This document is generated to distribute health, safety and environmental data. It is not a specification sheet and none of the displayed data should be construed
as a specification. Information on this SDS sheet was obtained from sources which we believe are reliable, and we believe that the information is complete and accurate.
However, the information is provided without any warranty, express or implied, regarding its correctness. Some of the information presented and conclusions drawn are from
sources other than direct test data of the substance. The conditions or methods of handling, storage, use and disposal of the product are beyond our control and may also be
beyond our knowledge. It is the user’s responsibility to determine the suitability of any material for a specific purpose and to adopt such safety precautions as may be necessary.
If the product is used as a component in another product, this SDS information may not be applicable. For these reasons, we do not assume any responsibility and expressly
disclaim liability for any loss, damage or expense arising out of or in any way connected with the handling, storage, use or disposal of this product.
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